Tadalafil belupo

Package leaflet: Information for the patient

Tadalafil Belupo, 5 mg, coated tablets
Tadalafilum
Please read the entire leaflet carefully before using the medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents

1. What Tadalafil Belupo is and what it is used for
2. Important information before taking Tadalafil Belupo
3. How to take Tadalafil Belupo
4. Possible side effects
5. How to store Tadalafil Belupo
6. Contents of the package and other information

1. What Tadalafil Belupo is and what it is used for

Tadalafil Belupo contains the active substance tadalafil, which belongs to a group of medicines called
phosphodiesterase type 5 inhibitors.
Tadalafil Belupo 5 mg is used to treat adult men:

• with erectile dysfunction. This is a condition in which a man cannot achieve or maintain an erection sufficient for sexual intercourse. Tadalafil has been shown to significantly improve the ability to achieve an erection sufficient for sexual intercourse. Following sexual stimulation, Tadalafil Belupo helps widen the blood vessels in the penis, allowing increased blood flow into the penis. As a result, erectile function improves. Tadalafil Belupo does not help patients who do not have erectile dysfunction. It is important to understand that Tadalafil Belupo does not work in treating erectile dysfunction without sexual stimulation. The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.
• with urinary symptoms associated with a common condition called benign prostatic hyperplasia. This is a condition in which the prostate gland enlarges with age. Symptoms include: difficulty starting urination, sensation of incomplete bladder emptying, and the need to urinate more frequently, even at night. Tadalafil Belupo improves blood flow and causes relaxation of the muscles in the prostate and bladder, which may relieve symptoms of benign prostatic hyperplasia. It has been shown that tadalafil alleviates these urinary symptoms as early as 1–2 weeks after starting treatment.

2. Important information before using Tadalafil Belupo

When not to use Tadalafil Belupo:

• if the patient is allergic to tadalafil or to any of the other ingredients of this medicine (listed in section 6).
• if the patient is taking organic nitrates in any form or other nitric oxide donors, e.g. amyl nitrite. This is a group of medicines ("nitrates") used in the treatment of angina pectoris (chest pain). It has been shown that tadalafil enhances the effect of these medicines. If the patient is taking nitrates in any form or is uncertain, they should inform their doctor.
• if the patient has severe heart disease or has had a heart attack within the last 90 days.
• if the patient has had a stroke within the last 6 months.
• if the patient has low blood pressure or uncontrolled high blood pressure.
• if the patient has ever experienced vision loss due to non-arteritic anterior ischemic optic neuropathy (NAION), referred to as "eye stroke".
• if the patient is taking riociguat. This is a medicine used to treat pulmonary hypertension (i.e. high blood pressure in the lungs) and chronic thromboembolic pulmonary hypertension (i.e. high blood pressure in the lungs caused by blood clots). It has been shown that PDE5 inhibitors such as tadalafil enhance the blood pressure-lowering effect of this medicine. If the patient is taking riociguat or is unsure, they should inform their doctor.

Warnings and precautions
Before starting treatment with Tadalafil Belupo, discuss it with your doctor or pharmacist.
Please note that sexual activity involves some risk in patients with heart disease, as it places additional strain on the heart. If you have any heart problems, inform your doctor.
Benign prostatic hyperplasia and prostate cancer may have similar symptoms; therefore, the doctor will perform tests to rule out prostate cancer before starting treatment with Tadalafil Belupo for symptoms of benign prostatic hyperplasia.
Tadalafil Belupo is not used to treat prostate cancer.
Before taking this medicine, the patient should inform the doctor if any of the following conditions apply:

• sickle cell anemia (abnormal shape of red blood cells).
• multiple myeloma (a cancer of the bone marrow).
• leukemia (a blood cell cancer).
• any deformity of the penis.
• severe liver disease.
• severe kidney disease.

It is not known whether Tadalafil Belupo is effective in patients:

• who have undergone pelvic surgery.
• who have undergone total or partial removal of the prostate gland with nerve-sparing techniques (nerve-sparing radical prostatectomy).

If sudden worsening of vision, sudden vision loss, or distorted, dimmed vision occurs during treatment with tadalafil, stop taking Tadalafil Belupo immediately and contact a doctor without delay.
In some patients taking tadalafil, hearing loss or sudden decrease in hearing has been observed.
Although it is not known whether this event is directly related to the use of tadalafil, if hearing loss or sudden decrease in hearing occurs, stop taking Tadalafil Belupo and contact a doctor immediately.
Tadalafil Belupo is not intended for use in women.
Children and adolescents
Tadalafil Belupo is not intended for use in children and adolescents under 18 years of age.
Tadalafil Belupo and other medicines
Tell your doctor about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Do not take Tadalafil Belupo if you are using nitrates.
Tadalafil Belupo may affect the action of other medicines or other medicines may affect the action of Tadalafil Belupo. Inform your doctor or pharmacist if you are taking any of the following medicines:

• alpha-blockers (used to treat high blood pressure or urinary symptoms caused by benign prostatic hyperplasia).
• other medicines used to treat high blood pressure.
• riociguat.
• 5-alpha-reductase inhibitors (used to treat symptoms of benign prostatic hyperplasia).
• medicines such as oral ketoconazole (used to treat fungal infections) and protease inhibitors used in the treatment of AIDS or HIV infection.
• phenobarbital, phenytoin, and carbamazepine (anticonvulsant medicines).
• rifampicin, erythromycin, clarithromycin, or itraconazole.
• other treatments for erectile dysfunction.

Tadalafil Belupo, alcohol consumption, and fertility
Information regarding the effect of alcohol is provided in section 3. Grapefruit juice may affect the effectiveness of Tadalafil Belupo, and therefore caution should be exercised when consuming it. For further information, consult your doctor.
Fertility
When the medicine was administered to dogs, a reduction in sperm production in the testes was observed. Reduced sperm concentration has been observed in some men. It is unlikely that this would lead to infertility.
Driving and operating machinery
Dizziness has been reported in some men taking tadalafil during clinical trials; therefore, patients should carefully assess their response to the medicine before deciding to drive or operate machinery.
Tadalafil Belupo contains lactose
If the patient has previously been diagnosed with intolerance to certain sugars, they should consult their doctor before taking this medicine.
Tadalafil Belupo contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, meaning the medicine is considered "sodium-free".

3. How to use Tadalafil Belupo

This medicine should always be taken exactly as directed by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist.
Tadalafil Belupo tablets are intended for oral use in men only. Swallow the tablet whole with a small amount of water. The tablets may be taken with or without food.
Alcohol consumption may cause a temporary decrease in blood pressure. If you have taken or plan to take Tadalafil Belupo, you should not consume large amounts of alcohol (blood alcohol concentration of 0.08% or higher), as this may increase the risk of experiencing dizziness upon standing.

Treatment of erectile dysfunction
The recommended dose is one 5 mg tablet taken once daily at approximately the same time each day.
Your doctor may reduce the dose to 2.5 mg depending on your individual response to Tadalafil Belupo. In such case, the 2.5 mg tablet should be used.
The 2.5 mg dose of Tadalafil Belupo is not registered on the market. It is necessary to use a medicine registered by another marketing authorisation holder containing tadalafil 2.5 mg.
Do not take Tadalafil Belupo more often than once a day.
Taking Tadalafil Belupo once daily allows achieving an erection following sexual stimulation at any time within 24 hours. Daily administration of Tadalafil Belupo may be beneficial for men who plan to engage in sexual activity two or more times per week.
It is important to be aware that Tadalafil Belupo does not work in the absence of sexual stimulation.
The patient and his partner should engage in foreplay, just as they would if the patient were not taking medication for erectile dysfunction.
Alcohol consumption may affect the patient's ability to achieve an erection.

Treatment of symptoms of benign prostatic hyperplasia
The dose is one 5 mg tablet taken once daily at approximately the same time each day. If the patient has both benign prostatic hyperplasia and erectile dysfunction, the dose remains unchanged at one 5 mg tablet once daily.
Do not take Tadalafil Belupo more than once a day.

Taking more than the recommended dose of Tadalafil Belupo
Inform your doctor immediately. Adverse effects described in section 4 may occur.

Missed dose of Tadalafil Belupo
Take the missed dose as soon as you remember, but do not take a double dose to make up for the missed tablet. Do not take Tadalafil Belupo more than once a day.
If you have any further doubts about the use of this medicine, consult your doctor or pharmacist.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
These reactions are usually mild or moderate.
If any of the adverse reactions listed below occur, stop taking the medicine and
seek immediate medical advice:
allergic reactions, including rashes (uncommon).
chest pain – do not use nitrates, but seek immediate medical help (uncommon).
priapism, prolonged and possibly painful erection after taking Tadalafil Belupo (rare). If such an erection occurs and lasts continuously for more than 4 hours, seek immediate medical advice.
sudden loss of vision (rare), distorted, blurred, or dim central vision, or sudden worsening of vision (frequency not known).

Other reported adverse reactions:
Common (observed in 1 to 10 out of 100 patients)
headache, back pain, muscle pain, pain in arms and legs, facial flushing, nasal congestion, and indigestion.

Uncommon (observed in 1 to 10 out of 1,000 patients)

• dizziness, abdominal pain, nausea, vomiting, regurgitation of stomach contents into the oesophagus, blurred vision, eye pain, breathing difficulties, presence of blood in urine, prolonged erection, sensation of heart palpitations, rapid heartbeat, high blood pressure, low blood pressure, nosebleeds, tinnitus, swelling of hands, feet or ankles, and feeling of fatigue.

Rare (observed in 1 to 10 out of 10,000 patients)

• fainting, seizures and transient memory loss, eyelid swelling, eye redness, sudden hearing loss and urticaria (itchy, red skin swellings), bleeding from penis, presence of blood in semen, and increased sweating.

Heart attack and stroke have also been rarely reported in men taking tadalafil. Most of these men had pre-existing heart conditions before starting treatment with this medicine.
There have been reports of rare cases of partial, transient or permanent vision loss or visual impairment in one or both eyes.
A few additional rare adverse reactions have been reported in men taking tadalafil, which were not observed during clinical trials. These include:

• migraine, facial swelling, severe allergic reactions causing swelling of the face or throat, severe skin rashes, disorders manifesting as blood flow to the eyes, irregular heartbeat, angina pectoris, and sudden cardiac death,
• distorted, blurred, dim central vision or sudden worsening of vision (frequency not known).

Adverse reaction: dizziness has been reported more frequently in men over 75 years of age taking tadalafil. Diarrhoea has been reported more frequently in men over 65 years of age taking tadalafil.

Reporting of adverse reactions
If any adverse effects occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Tadalafil Belupo

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister pack following "EXP".
The expiry date refers to the last day of the stated month.
The batch number is indicated after "Lot".
No special storage instructions apply.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Tadalafil Belupo contains

• The active substance is tadalafil. Tadalafil Belupo 5 mg: one coated tablet contains 5 mg of tadalafil.
• The other ingredients are:
  Tablet core: anhydrous lactose, sodium croscarmellose, sodium lauryl sulfate, hydroxypropylcellulose, polysorbate 80, magnesium stearate.
  Tablet coating: hypromellose 2910, monohydrate lactose, titanium dioxide (E 171), triacetin, talc, yellow iron oxide (E 172).

What Tadalafil Belupo looks like and contents of the pack
Tadalafil Belupo 5 mg: yellow, biconvex, caplet-shaped coated tablet, marked with "T5" on one side and smooth on the other side.
Length: 8.2 mm, width: 4.1 mm.
Tadalafil Belupo 5 mg: available in blister packs containing 28 tablets.

Marketing Authorisation Holder
Belupo lijekovi i kozmetika d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia

Manufacturer/Importer
Belupo lijekovi i kozmetika d.d.
Ulica Danica 5
48 000 Koprivnica
Croatia
Genepharm S.A.
18th km Marathonos Avenue
15351 Pallini Attiki
Greece

This medicinal product is authorised in the European Economic Area countries under the following names:
Poland: Tadalafil Belupo
Portugal: Tadalafil Belupo
Czech Republic: Tadalafil Belupo
Croatia: Tadalafil Belupo 5 mg filmom obložene tablete
Slovakia: Tadalafil Belupo 5 mg filmom obalené tablety
Slovenia: Tadalafil Belupo 5 mg filmsko obložene tablete